Initiation of GLP Tox Study definition

Initiation of GLP Tox Study means the date of the approval by the JRC of the final protocol for a study of the relationship between dose and its effects on the exposed animal, where (i) the study is to be conducted in accordance with Good Laboratory Practice standards and (ii) the study has been designed in expectation that the results may support establishment of a safe starting dose of the Product in human clinical studies (a “GLP Tox Study”).
Sample 1Sample 2
Initiation of GLP Tox Study means the date that an animal is first dosed with the Development Candidate of a Collaboration Product for the applicable Collaboration Target, in a study of the relationship between dose and its effects on the exposed animal, where (i) the study is a chronic toxicology study to be conducted in accordance with Good Laboratory Practice standards and (ii) the study has been designed in expectation that the results may support establishment of a safe starting dose of the Collaboration Product for a Phase I Study for human therapeutic use.
Sample 1Sample 2
Initiation of GLP Tox Study means the date that an animal is first dosed with the Product in a GLP Tox Study.
Sample 1Sample 2

Examples of Initiation of GLP Tox Study in a sentence

  • Roche shall pay Dicerna’s fully burdened manufacturing costs for supply of Additional Dicerna Compounds as requested by Roche for use in activities that will occur after Initiation of GLP Tox Study, and otherwise Roche shall have responsibility at its own expense for the supply of all Compounds, in each case for use in the R&D Collaboration.

  • During the Target Term with respect to Compounds Directed To a given Selected Target, except where otherwise set forth in the applicable Research Plan, Dicerna shall have responsibility at its own expense for the supply of Additional Dicerna Compounds for use in research activities conducted by Dicerna up to Initiation of GLP Tox Study for such Compound.

  • For avoidance of doubt, any supply of Additional Dicerna Compounds by Dicerna to Roche prior to the Initiation of GLP Tox Study for use in or after the Initiation of GLP Tox Study (including manufacturing reservation and cancelation fees incurred under the Research Plan), shall be reimbursed to Dicerna by Roche.

Related to Initiation of GLP Tox Study

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.